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Iron Deficiency AnaemiaPhase 3AEGIS-1NCT01340872

Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Ulcerative Colitis (AEGIS-1)

A Phase 3 study testing ST10-021 in people with Iron Deficiency Anaemia and Inflammatory Bowel Disease, run by Shield Therapeutics.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether ST10-021, an oral ferric iron preparation, is safe and effective in the treatment of iron deficiency anaemia (IDA) in subjects with non-active ulcerative colitis (UC). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ST10-021
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
128 participants
Where
No sites listed yet
Study dates
Aug 2011to Oct 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Competency to understand and sign the IEC/IRB approved informed consent form prior to any study mandated procedure, and willing/able to comply with study requirements
  • Age ≥ 18 years
  • Current diagnosis of quiescent UC as defined by SCCAI score of < 4
  • Current diagnosis of IDA as defined by Hb ≥ 9.5 g/dl and <12.0 g/dl for women and ≥ 9.5 g/dl and <13.0 g/dl for men; ferritin < 30 µg/l
  • Prior OFP failure as defined per protocol
  • If receiving protocol-allowed immunosuppressant must be on stable dose
  • Females of childbearing potential must agree to use a reliable method of contraception

Who cannot join

  • Anaemia due to any cause other than iron deficiency
  • Intramuscular or intravenous injection or administration of depot iron preparation, blood infusions, or erythropoietin within 3 months
  • Oral iron supplementation use within 1 month
  • Use of immunosuppressant with known effect of anaemia induction within 1 month
  • Vitamin B12 or Folic Acid injection/infusion within 4 weeks
  • Untreated Vitamin B-12 or Folic Acid deficiency
Show all 18Show fewer
  • Known hypersensitivity or allergy to ST10-021 or components of the study medication, or contraindication for treatment with iron preparations
  • Other chronic or acute inflammatory or infectious diseases
  • Creatinine > 2.0 mg/dl
  • AST or ALT levels ≥ 5 times the upper limit of normal
  • Cardiovascular, liver, renal, hematologic, gastrointestinal, immunologic, endocrine, metabolic, or central nervous system disease that may adversely affect the safety of the subject and/or efficacy of the study drug or severely limit the lifespan of the subject
  • History of malignancy within the past 5 years (except in situ removal of basal cell carcinoma)
  • Significant neurologic or psychiatric symptoms resulting in disorientation, memory impairment, or inability to report accurately that might interfere with treatment compliance, study conduct or interpretation of the results
  • Participation in another interventional clinical study within 30 days or during the study
  • Inmates of a psychiatric ward, prison, or other state institution
  • Investigator or any other team member involved directly or indirectly in the conduct of the clinical study
  • Scheduled or expected hospitalization and/or surgery during the course of the study
  • Females who are pregnant or lactating

About this study

Official title: A Prospective, Multicentre, Randomised, Double-blind, Placebo Controlled Study With Oral ST10-021 for the Treatment of Iron Deficiency Anaemia in Subjects With Quiescent Ulcerative Colitis Where Oral Ferrous Preparations Have Failed or Cannot be Used (AEGIS 1)

The purpose of this study is to determine whether ST10-021, an oral ferric iron preparation, is safe and effective in the treatment of iron deficiency anaemia (IDA) in subjects with non-active ulcerative colitis (UC).

Read the detailed description

As no curative treatment is currently available for ulcerative colitis (UC), treatment options are restricted to controlling symptoms, maintaining remission and preventing relapse. As such, treatment of iron deficiency anaemia (IDA), a key symptom of the disease, is integral to the medical management of UC. Iron deficiency anaemia in UC is a chronically debilitating disorder which has a significant impact on the quality of life of affected subjects. Characteristic symptoms of IDA include chronic fatigue, headache, and subtle impairment of cognitive function. Up to one third of subjects with UC suffer from recurrent anaemia, with hospitalization required in severe cases. First line standard therapy for mild to moderate IDA in UC is typically oral ferrous products (OFP), however this is often not successful. Many subjects are intolerant and suffer from continuously occurring side effects, occasional exacerbation of inflammatory lesions and failure to correct iron deficiency. Common adverse effects of OFP include nausea, epigastric discomfort and constipation, all of which are dose-related and appear especially evident in subjects with UC.

As compared to oral ferrous iron, oral ferric iron can be administered with improved tolerability and the total dose exposure of unabsorbed iron within the gastrointestinal tract is significantly reduced. In addition, the iron is retained in its chelated form if not absorbed and this may reduce the risk of irritation within the gastrointestinal tract. Clinical studies conducted to date provide preliminary evidence for the therapeutic potential of ST10-021 in patients with IDA in Inflammatory Bowel Disease, including UC.

The purpose of this study is to determine whether ST10-021 is safe and effective in the treatment of IDA in subjects with non-active UC. In an effort to target an underserved population, the study will include only those subjects who have failed OFP in the past, or where OFP cannot be used.

Being tested
ST10-021, Placebo Comparator
Keywords
iron deficiency, anaemia, inflammatory bowel disease, ulcerative colitis
Medical subject headings
Anemia, Iron-Deficiency, Inflammatory Bowel Diseases, Colitis, Ulcerative, Iron Deficiencies, Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ST10-021Drug

    Also called Ferric Trimaltol, Ferric maltol, Feraccru

    30 mg capsules to be taken orally twice a day for 12 weeks

  • Placebo ComparatorDrug

    Matching sugar pill to be taken orally twice a day for 12 weeks

Study groups in NCT01340872
Study groupRoleWhat they receive
ST10ExperimentalST10 (Ferric Maltol) 30mg capsules, taken orally twice a day
Receives: Drug: ST10-021
PlaceboPlacebo comparatorMatching placebo capsules for ST10 (Ferric Maltol), taken orally twice a day
Receives: Drug: Placebo Comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Haemoglobin (Hb) Concentration From Baseline to Week 12 (Full Analysis Set, FAS)

    Primary efficacy endpoint, defined as the change in Hb concentration from Baseline to Week 12. Baseline was defined as the pre-dose Hb concentration measured at the Randomisation Visit (Week 0). Missing Randomisation Hb values were replaced by Screening Hb values, if the randomisation was within the protocol-specified window. Hb concentration (g/dL) was analysed by a central laboratory from blood samples collected at every clinic visit: Screening, Randomisation (Week 0), Weeks 4, 8, 12, 14, 16, 20, 24, 36, 48, 64, Weeks 14 to 64 were open-label. The baseline, absolute concentration and change from baseline in Hb at all post-randomisation visits were listed and summarised by week using descriptive statistics. An analysis of covariance (ANCOVA) was used to analyse the primary endpoint; this included treatment, gender and disease as factors and baseline Hb as a covariate.

    Measured: Baseline to Week 12 - double-blind phase

Secondary outcomes (15)

  1. Proportion of Subjects That Achieved ≥1 g/dL Change From Baseline in Hb Concentration at Week 12 (Full Analysis Set, FAS)

    Logistic regression analysis of proportion of subjects that achieved ≥1 g/dL change from baseline in Hb concentration at Week 12 in the double-blind phase

    Measured: Subjects that achieved ≥1 g/dL change from baseline in Hb concentration at Week 12 - double-blind phase

  2. Proportion of Subjects That Achieved ≥2 g/dL Change From Baseline in Hb Concentration at Week 12 (Full Analysis Set, FAS)

    Logistic regression analysis of proportion of subjects that achieved ≥2 g/dL change from baseline in Hb concentration at Week 12 in the double-blind phase

    Measured: Baseline to Week 12 - double-blind phase

  3. Proportion of Subjects That Achieved Hb Concentration Within Normal Range at Week 12 (Full Analysis Set, FAS)

    Logistic regression analysis of proportion of subjects that achieved Hb concentration within normal range at Week 12 - end of double-blind phase

    Measured: Baseline to Week 12 - double-blind phase

  4. Change in Hb Concentration From Baseline to Week 4 (Full Analysis Set, FAS)

    ANCOVA analysis of the change in Hb concentration from Baseline to Week 4 of the double-blind phase - Full Analysis Set, multiple imputation

    Measured: Baseline to Week 4 - double-blind phase

  5. Change in Hb Concentration From Baseline to Week 8 (Full Analysis Set, FAS)

    ANCOVA analysis of Change in Hb concentration from Baseline to Week 8 of double-blind phase - FAS, multiple imputation

    Measured: Baseline to Week 8 - double-blind phase

  6. Change in Haemoglobin Concentration From Baseline to Week 16 (Full Analysis Set, FAS)

    Change in Haemoglobin Concentration from Baseline to Week 16 (FAS), after 12-week double-blind phase and first 4 weeks of open-label ST10 treatment.

    Measured: Baseline to Week 16 - open-label phase

  7. Change in Haemoglobin Concentration From Baseline to Week 20 (Full Analysis Set, FAS)

    Change in Haemoglobin Concentration from Baseline to Week 20 (FAS), after 12-week double-blind phase and then 8 weeks of open-label ST10 treatment

    Measured: Baseline to Week 20 - open-label phase

  8. Change in Haemoglobin Concentration From Baseline to Week 24 (Full Analysis Set, FAS)

    Change in Haemoglobin Concentration from Baseline to Week 24 (FAS), after 12-week double-blind phase and then 12 weeks of open-label ST10 treatment

    Measured: Baseline to Week 24 - open-label phase

  9. Change in Haemoglobin Concentration From Baseline to Week 36 (Full Analysis Set, FAS)

    Change in Haemoglobin Concentration from Baseline to Week 36 (FAS), after 12-week double-blind phase and then 24 weeks of open-label ST10 treatment

    Measured: Baseline to Week 36 - open-label phase

  10. Change in Haemoglobin Concentration From Baseline to Week 48 (Full Analysis Set, FAS)

    Change in Haemoglobin Concentration from Baseline to Week 48 (FAS), after 12-week double-blind phase and then 36 weeks of open-label ST10 treatment

    Measured: Baseline to Week 48 - open-label phase

  11. Change in Haemoglobin Concentration From Baseline to Week 64 (Full Analysis Set, FAS)

    Change in Haemoglobin Concentration from Baseline to Week 64 (FAS), after 12-week double-blind phase and then 52 weeks of open-label ST10 treatment

    Measured: Baseline to Week 64 - open-label phase

  12. Change in Haemoglobin Concentration From Baseline to Week 64 EOS (Full Analysis Set, FAS)

    Change in Haemoglobin Concentration from Baseline to Week 64 EOS (FAS) - Week 64 was re-categorised as Week 64 EOS for those subjects who withdrew from the study early and the 'Week 64' visit was outside the visit window of 64 weeks ± 2 days

    Measured: Baseline to Week 64 EOS - open-label phase

  13. Proportion of Subjects That Achieved Haemoglobin Concentration Within Normal Range at Week 16 (Full Analysis Set, FAS)

    Proportion of subjects that achieved Haemoglobin Concentration within normal range at Week 16 (Full Analysis Set), after 12-week double-blind phase and first 4 weeks of open-label ST10 treatment

    Measured: Baseline to Week 16 - open-label phase

  14. Proportion of Subjects That Achieved Haemoglobin Concentration Within Normal Range at Week 36 (Full Analysis Set, FAS)

    Proportion of subjects that achieved Haemoglobin Concentration within normal range at Week 36 (Full Analysis Set), after 12-week double-blind phase and 24 weeks of open-label ST10 treatment

    Measured: Baseline to Week 36 - open-label phase

  15. Proportion of Subjects That Achieved Haemoglobin Concentration Within Normal Range at Week 64 (Full Analysis Set, FAS)

    Proportion of subjects that achieved Haemoglobin Concentration within normal range at Week 64 (Full Analysis Set), after 12-week double-blind phase and 52 weeks of open-label ST10 treatment

    Measured: Baseline to Week 64 - open-label phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionOct 2013
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01340872
Sponsor's protocol ID
ST10-01-301
Other IDs
2010-023588-16
Acronym
AEGIS-1
Status last verified
Oct 2020
First submitted
19 Apr 2011
Last updated
30 Oct 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gasche C, Ahmad T, Tulassay Z, Baumgart DC, Bokemeyer B, Buning C, Howaldt S, Stallmach A; AEGIS Study Group. Ferric maltol is effective in correcting iron deficiency anemia in patients with inflammatory bowel disease: results from a phase-3 clinical trial program. Inflamm Bowel Dis. 2015 Mar;21(3):579-88. doi: 10.1097/MIB.0000000000000314.

    PubMed 25545376

  • Schmidt C, Ahmad T, Tulassay Z, Baumgart DC, Bokemeyer B, Howaldt S, Stallmach A, Buning C; AEGIS Study Group. Ferric maltol therapy for iron deficiency anaemia in patients with inflammatory bowel disease: long-term extension data from a Phase 3 study. Aliment Pharmacol Ther. 2016 Aug;44(3):259-70. doi: 10.1111/apt.13665. Epub 2016 May 29.

    PubMed 27237709

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ST10-021 in people with Iron Deficiency Anaemia and Inflammatory Bowel Disease, run by Shield Therapeutics.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Haemoglobin (Hb) Concentration From Baseline to Week 12 (Full Analysis Set, FAS) (time frame: Baseline to Week 12 - double-blind phase). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01340872, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2020.

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